NCT01318720

Brief Summary

Neck pain continues to be a prevalent condition in our society. Manual therapy (hands on techniques for the treatment of neck pain is an intervention commonly implemented in clinical practice. Recently researchers and clinicians have implemented manual therapy techniques to the thoracic spine (midback) to treat patients with neck pain. To date no studies have examined the short-term combined effects of thoracic spine manual therapy and cervical spine manual therapy in the treatment of patients with mechanical neck pain. The purpose this study is to assess the combined effects of thoracic spine thrust manipulation with cervical spine non-thrust manipulation in patients with neck pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

March 17, 2011

Last Update Submit

April 6, 2015

Conditions

Neck Pain

Keywords

Neck PainThrust ManipulationNon-Thrust Manipulation

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index (NDI)

    Neck Disability Index (NDI) is a disease-specific outcome measure specifically used in patients with neck pain. The NDI has been shown to be reliable and valid in individuals with mechanical neck pain.

    Short-term outcome 1 week

Secondary Outcomes (1)

  • Global Rating of Change (GROC)

    Short-term outcome 1 week

Study Arms (1)

Manipulation

EXPERIMENTAL

The experimental group is receiving thoracic spine thrust manipulation and cervical spine non-thrust manipulation.

Other: Manual Therapy

Interventions

Manual TherapyOTHER

Thrust manipulation is a type of manual therapy that clinicians apply using a high-velocity, low-amplitude thrust directed at a joint(s)

Manipulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Neck pain of less than 3 months
  • No symptoms below the shoulder
  • Baseline Neck Disability Index score of 10 or greater

You may not qualify if:

  • Red flags noted in the patient's Medical Screening Questionnaire (i.e. tumor, fracture, metabolic disease, rheumatoid arthritis, osteoporosis, prolonged use of steroid, etc)
  • History of whiplash injury within the past two months
  • Diagnosis of cervical spinal stenosis
  • Uni-lateral or bi-lateral upper extremity radicular symptoms
  • Evidence of central nervous system involvement
  • Two or more positive neurological signs consistent with nerve root involvement: myotomal muscle weakness, dermatomal sensory loss, diminished or absent reflexes
  • Prior surgery to the neck or thoracic spine
  • Pending legal action regarding their neck pain, or patients with no fault or workers compensation claims
  • Insufficient English language skills to complete the questionnaires
  • Inability to comply with treatment and follow-up schedule
  • Women who may be pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Long Island University

Brooklyn, New York, 11201, United States

Location

Masefield Cavallaro Physical Therapy

Brooklyn, New York, 11228, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Michael Masaracchio, PT, DPT, PhD(c), OCS, SCS

    Masefield Cavallaro Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Staff Physical Therapist

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 18, 2011

Study Start

November 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

US(2)